A Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis

March 26, 2008 updated by: Abbott

A Phase III, Prospective, Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis

To determine the safety and efficacy of paricalcitol capsules as compared to placebo for treatment of secondary hyperparathyroidism by decreasing serum intact parathyroid hormone levels in end stage renal disease subjects on peritoneal dialysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Krakow, Poland
      • Krakow, Poland, 30-501
  • United States
    • California
      • Los Angeles, California, United States, 90095
    • Colorado
      • Denver, Colorado, United States, 80230
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
    • Florida
      • Fort Myers, Florida, United States, 33919
      • Tampa, Florida, United States, 33603
    • Georgia
      • Savannah, Georgia, United States, 31405
    • Illinois
      • Evanston, Illinois, United States, 60201
      • Maywood, Illinois, United States, 60153
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Nevada
      • Las Vegas, Nevada, United States, 89102
    • New York
      • Mineola, New York, United States, 11501
    • Ohio
      • Cincinnati, Ohio, United States, 45220
      • Cincinnati, Ohio, United States, 45206
      • Cleveland, Ohio, United States, 44195
    • Oregon
      • Portland, Oregon, United States, 97210
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Memphis, Tennessee, United States, 38105
      • Nashville, Tennessee, United States, 37205
    • Texas
      • Houston, Texas, United States, 77030
      • Lubbock, Texas, United States, 79430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is greater than or equal to 18 years.
  • Subject is diagnosed with ESRD and must be on continuous PD 7 days per week for at least 2 months prior to Screening Phase.
  • If female, subject is either not of childbearing potential or is of childbearing potential and practicing one of the recommended methods of birth control.
  • If female, subject must have a negative serum pregnancy test prior to treatment.
  • If female, subject is not breastfeeding.
  • Subject is undergoing full PD regimen and is expected to remain on this PD regimen for the duration of the study.
  • For those subjects who have been taking a phosphate binder prior to therapy, the subject has been on a stable type of phosphate binder at least 4 weeks prior to the Pre-Treatment Phase.
  • For entry into the Pretreatment Phase the subject must have: Calcium level less than or equal to 10.5 mg/dL and Ca x P level less than or equal to 65.
  • For entry into the Treatment Phase the subject must have: iPTH greater than or equal to 300 pg/mL, calcium level of 8.0 to 10.5 mg/dL, inclusive, and Ca x P less than or equal to 65.
  • Subject has voluntarily signed and dated an IRB approved informed consent.

Exclusion Criteria:

  • Subject has history of an allergic reaction or significant sensitivity to drugs similar to the study drug
  • Subject has had active peritonitis within 1 month prior to screening phase.
  • Subject has had more than one episode of peritonitis within 4 months prior to screening phase.
  • Subject has received a partial parathyroidectomy within 1 year prior to screening phase.
  • Subject has had acute renal failure within 3 months of screening phase.
  • Subject has chronic gastrointestinal disease.
  • Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the screening phase or will require these medications greater than 3 weeks in the study.
  • Subject has a current malignancy or clinically significant liver disease.
  • Subject has a history of drug or alcohol abuse within 6 months prior to screening phase.
  • Subject has evidence of poor compliance with diet, medication, or PD.
  • Subject has participated in any investigational drug or device study within 4 weeks prior to the treatment phase.
  • Subject is taking maintenance calcitonin, glucocorticoids, or other drugs that may affect calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy.
  • For any reason, subject is considered by the investigator to be an unsuitable candidate to receive paricalcitol capsules.
  • Subject is known to be HIV positive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: B
Drug: paricalcitol capsules
baseline iPTH/60
Other Names:
  • Zemplar
  • ABT-358
  • paricalcitol
Placebo Comparator: A
Drug: paricalcitol capsules
baseline iPTH/60
Other Names:
  • Zemplar
  • ABT-358
  • paricalcitol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The achievement of two consecutive greater than or equal to 30% decreases from baseline iPTH levels.
Time Frame: 12 weeks
12 weeks
The incidence of clinically meaningful hypercalcemia and elevated Ca x P.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

November 1, 2002

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 26, 2008

First Posted (Estimate)

March 28, 2008

Study Record Updates

Last Update Posted (Estimate)

March 28, 2008

Last Update Submitted That Met QC Criteria

March 26, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001-015
  • R&D/02/655

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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